Federalwide Assurances

A Federalwide Assurance (FWA) is a declaration of compliance with federal regulations for the protection of human subjects in research. The federal Office for Human Research Protections (OHRP) approves FWAs for all human subjects research conducted or supported by the Department of Health and Human Services.

The OHRP also approves FWAs for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for research that they conduct or support.

Each institution engaged in human subjects research conducted or supported by the Department of Health and Human Services must have an approved FWA on file with OHRP. At Indiana University, the Human Subjects Office coordinates submissions and updates of FWAs for IU affiliates and partners.

The following is a list of FWAs for IU and its affiliates. Depending on your research locations, you may need to reference multiple FWA numbers.

Registering an institutional review board and obtaining a Federalwide Assurance are related but separate.

To receive Department of Health and Human Services support for research involving human subjects, an institution must have an FWA, and each FWA must designate at least one IRB registered with Office of Human Research Protections.

Before obtaining an FWA, an institution must either register its own IRB (an internal IRB) or designate an already registered IRB operated by another organization (an external IRB), after establishing a written agreement with that organization.

Indiana University has the following IRBs registered with Office of Human Research Protections:

• IRB00000219 – Indianapolis IRB-04
• IRB00000220 – Indianapolis IRB-01
• IRB00000222 – Bloomington IUB IRB
• IRB00004960 – Indianapolis IRB-07

To search for approved FWAs and registered Institutional Review Boards, visit the Office of Human Research Protections (OHRP) FWA database